ImmunArray Enters Partnership with Kindstar Global

Alliance with China-based diagnostic company to support joint
clinical studies and prepare for diagnostic product introduction in
Chinese markets

July 10, 2017 11:51 AM Eastern Daylight Time

RICHMOND, Va.--(EON: Enhanced Online News)--ImmunArray, a privately held molecular device company dedicated to the
development of novel, blood-based in vitro diagnostic tests, and
Kindstar Global Co., Ltd., a specialty clinical testing company based in
Wuhan, China with locations throughout mainland China, have forged a
partnership involving shared clinical studies and the launch of
ImmunArray’s lupus rule-out test in China as the initial product
offering.

“This partnership with Kindstar combines the resources of two innovative
diagnostic companies that are focused on finding solutions to the
diagnosis of autoimmune diseases, and we are extremely excited about the
possibilities that this alliance can afford both parties”

The companies will undertake joint clinical testing of up to 500 serum
samples from Chinese patients who are healthy as well as those with
symptoms consistent with systemic lupus erythematosus (SLE) or lupus.
The study will support the clinical implementation of ImmunArray’s
SLE-Key Rule-Out® test, which was introduced in U.S. markets in 2016.
Previous clinical trials have found the test delivers a differential
diagnosis with >90% sensitivity and >70% specificity.

ImmunArray will provide training to Kindstar staff in ImmunArray’s
Richmond facility and onsite in the first two labs in China. The
detection platform on which the ImmunArray manufactured iChip® test has
been cleared by the CFDA which will facilitate the introduction of the
first of the tests planned for the market.

The diagnosis and treatment of lupus is not simply an American challenge
but one that affects populations around the world. The Chinese
population has the second largest incidence of lupus in the world with
over 1 million patients identified with lupus in that country today.
ImmunArray is working closely with Peter Lipsky, M.D., co-founder of
AMPEL with whom ImmunArray announced a Strategic Partnership on World
Lupus Day in May 2017. Dr. Lipsky and AMPEL co-founder Dr. Amrie
Grammer, has had the good fortune to provide training to some of the
leaders of the Chinese academic rheumatology community and maintains
active collaborations with many. He will be a co-chair of the Scientific
Advisory Board with leading Chinese academic rheumatologists, making
recommendations to ImmunArray and Kindstar concerning their joint
venture.

“This partnership with Kindstar combines the resources of two innovative
diagnostic companies that are focused on finding solutions to the
diagnosis of autoimmune diseases, and we are extremely excited about the
possibilities that this alliance can afford both parties,” said Donna
Edmonds, CEO of ImmunArray.

“The business relationship and expanded market opportunity this provides
to Kindstar is an important part of our strategy to be the premier
specialty laboratory in China,” said Shiang Huang, M.D., Kindstar
founder and CEO. “We are focused on providing testing to a growing
number of specialists as they support patient care. This expanded
product line for rheumatologists is another demonstration of that
commitment.”

As part of the agreement, Kindstar will acquire the exclusive rights to
market ImmunArray’s SLE-Key Rule-Out test in China. The launch of the
product into the Chinese market is tentatively set for November 2017 and
will be formally announced at the internationally attended American
College of Rheumatology annual meeting in San Diego.

About ImmunArray

Founded in 2006 and co-located in Rehovot, Israel and Richmond, Va.,
ImmunArray’s novel blood-based testing platform supports the diagnosis
and management of complex acute and chronic immune and neurodegenerative
diseases. The company designs and analyzes sets of biomarkers known to
be linked to a particular condition and develops tests on platforms that
are most appropriate to facilitate the adoption of additional tests. The
company’s first commercial test, the SLE-Key® Rule-Out Test, is used to
assist physicians in ruling out Systemic Lupus Erythematosus (SLE) or
lupus as part of a differential diagnosis. The company has a pipeline of
products in development to support diagnosis and management of other
auto-immune and neurological diseases.

About Kindstar Co., Ltd.

Founded in 2003 and based in Wuhan, China, Kindstar Global Co., Ltd.
provides specialty clinical testing services throughout China. The
company offers esoteric diagnostic testing and laboratory testing
services to Chinese hospitals, including tertiary care hospitals. The
company has a long standing partnership with the Mayo Clinic and has
laboratory facilities in Beijing, Shanghai and Wuhan. It was formerly
known as Wuhan Kindstar Diagnostics Co., Ltd.